The Role of DLBS1033 in the Management of Acute Ischemic Stroke Patients: A Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Improvement in mNIHSS score
研究概览
简要总结
This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in acute ischemic stroke patients.
详细描述
Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 at a dose of 490 mg three times daily (as DLBS1033 group). Standard therapy used in the study will consist of: aspirin 80 mg, simvastatin 20 mg, vitamin B complex, and citicholine 250 mg/2 mL twice daily.
After hospital admission and diagnosis, patient will be handled according to the standard management for acute ischemic stroke applicable in the hospital. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study's regimens. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline, day 4, and day 8 of treatment (end of study); while safety examinations will be performed at baseline and end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with age of 18-75 years .
- •Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan.
- •Modified National Institutes of Health Stroke Scale (mNIHSS) score >=
- •Patients present at hospital and receiving first dose of study medication within 72 hours after the onset of the stroke symptoms.
- •Able to take oral medication.
排除标准
- •For females of childbearing potential: pregnancy and lactation period.
- •History of or current hemorrhagic stroke (within the last 3 months).
- •Transient ischemic stroke (TIA).
- •Patients with seizure at the onset of stroke.
- •History of serious head injury within the last 3 months.
- •History of major surgery within the last 3 months.
- •Serious cardiovascular conditions, such as myocardial infarction, CHF grade III and IV (NYHA classification), aorta dissection, and atrial fibrillation within the last 6 months.
- •Presence of severe renal or hepatic dysfunction
- •Presence of acute or chronic infections.
- •Thrombocytopenia (thrombocytes level < 150.000/ul).
- •Patients with higher risks of bleeding.
- •Uncontrolled hypertension (systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg).
- •Random plasma glucose >= 200 mg/dL.
- •Current or regular use of oral anticoagulants, antiplatelets other than study medication, and herbal medicines.
- •Hypersensitive to the investigational product(s).
研究组 & 干预措施
Control Group
Placebo will be administered orally, 3 x 1 tablet daily, for 8 days of study period
干预措施: Placebo (Drug)
DLBS1033 Group
DLBS1033 will be administered orally, 3 x 1 tablet daily, for 8 days of study period
干预措施: DLBS1033 (Drug)
结局指标
主要结局
Improvement in mNIHSS score
时间窗: 7 days after treatment initiation
Change in functional outcomes as measured by The Modified National Institute of Health Stroke Scale (mNIHSS) from its baseline value
次要结局
- Improvement in d-dimer level(7 days after treatment initiation)
- Improvement in MRS(7 days after treatment initiation)
- Renal function(7 days after treatment initiation)
- Hemostasis parameters(7 days after treatment initiation)
- Improvement in fibrinogen level(7 days after treatment initiation)
- Routine hematology(7 days after treatment initiation)
- Adverse events(7 days after treatment initiation)
- Liver function(7 days after treatment initiation)